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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016547
Receipt No. R000019146
Scientific Title A multi-institutional phase II study on safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for the lung
Date of disclosure of the study information 2015/05/01
Last modified on 2019/08/21

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Basic information
Public title A multi-institutional phase II study on safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for the lung
Acronym Phase II study on lung DT-SBRT
Scientific Title A multi-institutional phase II study on safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for the lung
Scientific Title:Acronym Phase II study on lung DT-SBRT
Region
Japan

Condition
Condition Lung cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and efficacy of dynamic tumor tracking stereotactic radiotherapy for lung cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes 2-year local control rate
Key secondary outcomes Overall survival, progression-free survival, local progression-free survival, adverse event, severe adverse event, accuracy in the treatment, dose-volume metrics

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Other
Interventions/Control_1 Dynamic tumor tracking radiotherapy using Vero4DRT
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) primary or metastatic lung cancer which satisfies the following conditions:
Primary lung cancer
(1)
(a) pathological or cytological diagnosis of primary lung cancer
(b) clinically diagnosed primary lung cancer with a consensus of multiple doctors based on tumor marker, CT, FDG-PET, etc.
(2) tumor diameter of 5cm or less and clinical stage of IA-IB diagnosed with imaging studies
Metastatic lung cancer
(1) clinically diagnosed metastatic lung cancer
(2) three or less tumors with diameters of 5cm or less without any extrapulmonary lesions which was diagnosed with imaging studies

2) Ineligibility to standard surgery confirmed by institutional thoracic surgeons, or patient's refusal of surgery
3) Predicted to satisfy dose constraints for the surrounding organ
4) Aged 20 years or more
5) ECOG-PS of 0 to 2
6) Able to keep the patient's position with the arms raised for 30 mins or more
7) Respiratory motion of 10 mm or more
Key exclusion criteria 1) history of radiotherapy to the same area
2) active interstitial pneumonia or pulmonary fibrosis
3) severe diabetes mellitus or collagen disease
4) female who are pregnant or in lactation
5) metal disease which prevents registration of the study
6) other issues which are considered to be inappropriate for the study by the doctors
Target sample size 48

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Mizowaki
Organization Kyoto University
Division name Dept of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine
Zip code 606-8507
Address 54, Shogoinkawaharacho, Sakyo, Kyoto
TEL 075-751-3417
Email mizo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Yukinori
Middle name
Last name Matsuo
Organization Kyoto University
Division name Dept of Radiation Oncology and Image-applied Therapy, Graduate School of Medicine
Zip code 606-8507
Address 54, Shogoinkawaharacho, Sakyo, Kyoto
TEL 075-751-3762
Homepage URL
Email ymatsuo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization AMED
Organization
Division
Category of Funding Organization Government offices of other countries
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethics Committee
Address Yoshida Konoe cho, Sakyo, Kyoto
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 京都大学医学部附属病院(京都府)、先端医療センター病院(兵庫県)、がん・感染症センター都立駒込病院(東京都)、京都桂病院(京都府)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 48
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2015 Year 04 Month 23 Day
Date of IRB
2015 Year 04 Month 23 Day
Anticipated trial start date
2015 Year 05 Month 01 Day
Last follow-up date
2020 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 02 Month 16 Day
Last modified on
2019 Year 08 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019146

Research Plan
Registered date File name
2018/09/20 AMED_肺追尾_プロトコル2017.07.05_マーカーなし.docx

Research case data specifications
Registered date File name
2017/01/11 厚労科研_肺追尾_症例登録用紙2016.06.27 - マーカーなし.docx

Research case data
Registered date File name
2020/02/28 AMED追尾多施設(肺)20200205.xlsx


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